The primary objective of this feasibility study is to evaluate the safety of DBS-f in patients with mild Alzheimer's disease by assessing all device and/or therapy related adverse events. The secondary objective is to preliminarily estimate the treatment effect size on the outcomes of interest at 12 months post-randomization. The objectives do not involve formal tests of hypotheses.

The study will assess the acute and long-term safety of the system. A detailed assessment of all device and/or therapy related adverse events will be conducted. [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Abnormal lab results that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.

Abnormal cardiovascular or neurovascular disorder that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.

Unstable doses of any medication prescribed for the treatment of memory loss or Alzheimer's disease.

Currently prescribed any non-AD medications that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.

Is unable or unwilling to comply with protocol follow-up requirements.

Has a life expectancy of < 1 year.

Is actively enrolled in another concurrent clinical trial.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608061